A Phase 2 interventional study of Albumin Infusion in Cirrhosis and Hepatic Encephalopathy, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center · Phase 2, Interventional, and Prevention
Hypothesis: Improvement in cognitive dysfunction with IV albumin in patients with cirrhosis with prior HE and MHE lasts for several weeks after albumin infusion has ended, and is due to persistent improvement in inflammatory markers, endothelial dysfunction, albumin function and gut microbial changes.
This will be a single-arm, single-blind sequential trial of IV 25% albumin and IV saline over 8 weeks with biological sampling and cognitive and health related quality of life (HRQOL) testing with each subject acting as their own control.
In outpatients with cirrhosis with prior HE who have cognitive impairment despite adequate therapy, how long the impact of albumin lasts and through which potential mechanism(s) needs to be determined.
A prior recent HEAL trial showed that patients with prior HE and current minimal hepatic encephalopathy (MHE) randomized to albumin experienced significant improvement in cognitive dysfunction and psychosocial quality of life. Moreover, these improvements persisted a week after the last albumin infusion, which was not seen in the placebo group. This was accompanied by an improvement in endothelial dysfunction, ischemia-modified albumin levels and inflammatory markers that persisted one week even after albumin discontinuation. The reported half-life of IV albumin is 2 weeks, but the function and the length of time of albumin's action in decompensated cirrhosis is lower, and further details surrounding albumin pharmacokinetics in this population remain unelucidated. The mechanisms and length of time albumin's potential improvement for patients with MHE after treatment discontinuation also require continued study.
Study design:
This will be a single-arm, single-blind sequential trial of IV 25% albumin and IV saline over 8 weeks with biological sampling and cognitive and health related quality of life (HRQOL) testing with each subject acting as their own control.
Th order of the albumin and placebo infusion and blind the infusions from the subjects and the assessors of the outcomes will be changed.
225 studies on the registry are indexed under Hepatic Encephalopathy; 53 are open to participants now.
This study's enrollment of 25 is below the median of 60 across 154 interventional studies indexed under Hepatic Encephalopathy.
Browse Hepatic Encephalopathy studies →Hunter Holmes Mcguire Veteran Affairs Medical Center is the lead sponsor of 31 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Compared within Hepatic Encephalopathy, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Fibrosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Saline given at the same volume as the albumin on visits the patients are assigned to it
Drug: Albumin Infusion
IV Albumin at 1.5g/kg ideal body weight
Drug: Albumin Infusion
Intravenous human serum albumin to be given at 1.5g/kg ideal body weight
Also known as: Albutein
Delta change in Psychometric Hepatic Encephalopathy Score (PHES) in Placebo phase vs Albumin phase
cognitive improvement (PHES score ranges from -15 to 5), higher is good
Time frame: 4 weeks each
EncephalApp Stroop change in Placebo phase vs Albumin phase
cognitive improvement (Stroop OffTime+OnTime in seconds will be evaluated); higher is worse
Time frame: 4 weeks each
Critical Flicker Frequency change in Placebo phase vs Albumin phase
cognitive improvement (Hz at which CFF is reached will be evaluated), higher is good
Time frame: 4 weeks each
Change in Sickness Impact Profile Placebo phase vs Albumin phase
Health-related quality of life change (SIP total, psychosocial and physical scores where a higher score indicates poor HRQOL willl be evaluated)
Time frame: 4 weeks each
Change in PROMIS-29 Placebo phase vs Albumin phase
Health-related quality of life change (Total PROMIS-29 score will be evaluated)
Time frame: 4 weeks each
Change in MELD-Na score Placebo phase vs Albumin phase
Liver disease severity change using MELD-Na; higher is worse
Time frame: 4 weeks each
Change in endotoxin binding protein Placebo phase vs Albumin phase
Change in endotoxin binding protein will be recorded in the serum; higher is worse
Time frame: 4 weeks each
Change in oxidized albumin Placebo phase vs Albumin phase
Change in oxidized albumin will be recorded in the serum ; higher is worse
Time frame: 4 weeks each
Change in ischemia modified albumin Placebo phase vs Albumin phase
Change in ischemia modified albumin will be recorded in the serum
Time frame: 4 weeks each
Change in stool bile acids Placebo phase vs Albumin phase
Change in stool bile acids (total, primary, secondary, conjugated/deconjugated) will be recorded
Time frame: 4 weeks each
Change in serum bile acids Placebo phase vs Albumin phase
Change in serum bile acids (total, primary, secondary, conjugated/deconjugated) will be recorded
Time frame: 4 weeks each
Change in serum Short-chain fatty acids Placebo phase vs Albumin phase
Change in serum Short-chain fatty acids (acetate, propionate, butyrate will be recorded
Time frame: 4 weeks each
Change in stool Short-chain fatty acids Placebo phase vs Albumin phase
Change in stool Short-chain fatty acids (acetate, propionate, butyrate will be recorded
Time frame: 4 weeks each
Change in stool bacterial alpha diversity Placebo phase vs Albumin phase
Change in Shannon diversity of stool bacteria
Time frame: 4 weeks each
Change in serum inflammatory cytokines Placebo phase vs Albumin phase
Change in IL-6, TNF-α, IL-10, IL-1β in serum
Time frame: 4 weeks each
Plan to share: No
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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Albumins
Hunter Holmes Mcguire Veteran Affairs Medical Center